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Nonsteroidal Anti-inflammatory Drug
Low-Dose Aspirin for Preeclampsia Prevention (ASAPP Trial)
Phase 3
Waitlist Available
Led By Line Malha, MD, MS
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal disease (proteinuria ≥300mg/day or estimated GFR<90mL/min/1.73 m2)
Autoimmune disease (e.g. systemic lupus erythematous, antiphospholipid syndrome)
Must not have
Contraindication to ASA therapy (including but not limited to allergy and high bleeding risk)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months for each patient (from recruitment until 6 weeks postpartum)
Awards & highlights
Summary
This trial is testing whether a higher dose of aspirin can help prevent preeclampsia, a dangerous complication of pregnancy.
Who is the study for?
This trial is for pregnant women over 18, under 16 weeks gestation with a history of preeclampsia or risk factors like chronic hypertension, diabetes, renal disease, or autoimmune disorders. It's not for those allergic to aspirin, at high bleeding risk, with major fetal malformations on ultrasound, or planning pregnancy termination.
What is being tested?
The study compares the effectiveness of two low-dose aspirin regimens (81mg vs. 162mg daily) in preventing severe or preterm preeclampsia in high-risk pregnant women. Participants will be randomly assigned to one of the dosages from a single center.
What are the potential side effects?
Aspirin may cause side effects such as gastrointestinal issues (like stomach pain and heartburn), increased bleeding tendency especially during delivery if taken close to labor onset, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have kidney issues with protein in my urine or low kidney function.
Select...
I have an autoimmune disease like lupus.
Select...
I am pregnant, under 16 weeks, and at risk for preeclampsia.
Select...
I have type 1 or type 2 diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take ASA due to an allergy or high risk of bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months for each patient (from recruitment until 6 weeks postpartum)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months for each patient (from recruitment until 6 weeks postpartum)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of preeclampsia with severe features
Incidence of preterm (<37 weeks) preeclampsia
Secondary outcome measures
Aspirin adherence
Aspirin compliance
Maternal and Fetal Outcomes
+1 moreOther outcome measures
Pre-Eclampsia
Trial Design
2Treatment groups
Active Control
Group I: 162mg ASAActive Control1 Intervention
Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day.
Group II: 81mg ASAActive Control1 Intervention
Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,318,786 Total Patients Enrolled
Line Malha, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney issues with protein in my urine or low kidney function.I cannot take ASA due to an allergy or high risk of bleeding.You have experienced blood clots in a previous pregnancy.You are planning to end a pregnancy.I have an autoimmune disease like lupus.I am pregnant, under 16 weeks, and at risk for preeclampsia.I have type 1 or type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: 162mg ASA
- Group 2: 81mg ASA
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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